Industrial Design

Bridging digital and physical in health products
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Many health products exist at the intersection of digital and physical. From wearable devices to remote monitoring hardware, industrial design is critical for adoption, compliance, and clinical efficacy.

Medical Device Design Principles

Physical health products must balance competing demands:

  • Clinical functionality: Does it capture accurate data?
  • User experience: Is it comfortable and easy to use?
  • Compliance: Does it meet regulatory standards?
  • Manufacturability: Can it be produced at scale?
  • Cost: Is it affordable for the target market?

Ergonomics for Health

Health devices are used by diverse populations in varied contexts:

  • Self-use: Can patients apply/use the device themselves?
  • Caregiver use: Is it easy for non-clinical caregivers?
  • Clinical use: Does it fit into clinical workflows?
  • Extended wear: Is it comfortable for continuous use?
  • Accessibility: Can users with limited dexterity use it?

Wearable Form Factors

The wearable market continues to expand. Key design considerations:

  • Skin contact: Material selection for comfort and hygiene
  • Battery life: Must match the intended use cycle
  • Water resistance: Patients wear devices during daily activities
  • Size and weight: Must not interfere with normal activities
  • Data connectivity: Bluetooth, cellular, or periodic sync?

Regulatory Considerations for Hardware

Hardware introduces additional regulatory complexity:

  • IEC 60601: Medical electrical equipment safety standard
  • ISO 14971: Risk management for medical devices
  • IP rating: Dust and water ingress protection
  • Biocompatibility: ISO 10993 for skin-contact materials
  • EMC compliance: Electromagnetic compatibility testing
  • Wireless certification: FCC (US), CE (EU), ISED (Canada)

Prototyping Methods

StageMethodPurpose
ConceptFoam models, 3D printsForm exploration, ergonomics testing
FunctionalBreadboard, ArduinoTechnical feasibility
ClinicalPre-production unitsUsability validation, clinical testing
RegulatoryProduction-equivalent unitsCertification testing, submissions
ManufacturingPilot productionProduction validation, quality testing